Completed

DOX-SL Treatment for Moderate to Severe AIDS-Related Kaposi's Sarcoma

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Doxorubicin hydrochloride (liposomal)

Drug
Who is being recruted

Blood-Borne Infections+21

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorSequus Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Patients receive DOX-SL every 3 weeks for a maximum of 20 cycles (including any cycles from a previous DOX-SL study). KS lesions are evaluated prior to administration of each treatment, at the end of the final treatment cycle, and at 4 weeks following the end of the final treatment. Patients who respond will be followed every 2 months for up to 1 year. Study treatment may be interrupted for up to 4 months because of complete response, development of opportunistic infections, or adverse drug effects.

NCT00002319
Principal SponsorSequus Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesDNA Virus InfectionsHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsNeoplasmsNeoplasms by Histologic TypeNeoplasms, Vascular TissueRetroviridae InfectionsRNA Virus InfectionsSarcomaSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsNeoplasms, Connective and Soft TissueAcquired Immunodeficiency SyndromeSarcoma, KaposiHIV Infections

Criteria

9 inclusion criteria required to participate
Moderate to severe AIDS-related Kaposi's sarcoma.
Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy provided these doses have been stable for at least 1 month.
Maintenance therapy for tuberculosis, fungal, and herpes infections.
Colony stimulating factors and erythropoietin.
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9 exclusion criteria prevent from participating
Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to an irreversibly compromised marrow function.
History of idiosyncratic or allergic reaction to anthracyclines.
Cytotoxic chemotherapy (other than in a qualifying Liposome Technology protocol) within the past 4 weeks.
Radiation or electron beam therapy within the past 3 weeks.
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 33 locations

East Bay AIDS Ctr

Berkeley, United StatesOpen East Bay AIDS Ctr in Google Maps

Pacific Oaks Med Group

Beverly Hills, United States

Hematology - Oncology Med Group of San Fernando Valley

Encino, United States

Dr Becky Miller

Los Angeles, United States
Completed33 Study Centers